The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Otoscope.
Device ID | K902205 |
510k Number | K902205 |
Device Name: | OTOSCOPE |
Classification | Otoscope |
Applicant | TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
Contact | David Grey |
Correspondent | David Grey TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106 |
Product Code | ERA |
CFR Regulation Number | 874.4770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-16 |
Decision Date | 1990-08-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OTOSCOPE 77875618 3905524 Live/Registered |
Smith, Richard J.H. 2009-11-18 |